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MyopiaNCT07512115

The Impact of 'A Miss Is as Good as a Mile': Is Compensation Necessary for Minimal Ocular Deviation in Myopic Laser Surgery?

A study testing Apply compensation to the Kappa angle. and Apply no compensation to the Kappa angle in people with Myopia and Refractive Ametropia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

The goal of this clinical trial is to evaluate the effect of intraoperative kappa-angle compensation on postoperative visual quality in patients undergoing small incision lenticule extraction (SMILE) using the VisuMax 800 platform. The study will enroll patients with myopia and a kappa-angle offset < 0.2 mm. Read more about this study

Who is it for?
Ages 18 to 40 years
Conditions the study is for
Myopia, Refractive Ametropia
What is being tested?
Apply compensation to the Kappa angle. and Apply no compensation to the Kappa angle
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
224 participants
Where
1 siteChina
Study dates
8 Apr 2026to 30 May 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 40 years
  • All sexes
  • No healthy volunteers
  • Adult

Who may be able to join

  • Patients aged 18 to 40 years with myopia or myopic astigmatism and stable refraction for >=1 year, whose refractive errors fall within the treatable range of and meet the indications for SMILE surgery.
  • Normal corneal morphology and corneal thickness meeting surgical requirements.
  • Preoperative corrected distance visual acuity (CDVA) >= 1.0.
  • Preoperative synthetic Kappa angle offset measured >= 0.10 mm and < 0.20 mm.
  • Voluntarily agree to undergo SMILE surgery on the VISUMAX 800 platform, understand the randomization scheme, and provide signed informed consent.

Who cannot join

  • History of prior ocular surgery, significant ocular trauma, or presence of corneal or ocular diseases that may affect the safety of refractive surgery.
  • Severe systemic diseases that may affect ocular healing or surgical safety.
  • Females who are pregnant or lactating.
  • Inability to cooperate as required to complete the procedure or follow-up visits.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

China1 site, 1 recruiting
  • Zhongshan Ophthalmic Center

    Guangzhou, Guangdong, 510060

    Guofu Huang, +86-20-66686748, huangguofu@gzzoc.com

    Recruiting

Other trials in China

About this study

Official title: Effect of Centration Compensation on Visual Quality in VisuMax 800 SMILE for Small Kappa Angles: A Randomized Trial

The goal of this clinical trial is to evaluate the effect of intraoperative kappa-angle compensation on postoperative visual quality in patients undergoing small incision lenticule extraction (SMILE) using the VisuMax 800 platform. The study will enroll patients with myopia and a kappa-angle offset < 0.2 mm.

The main questions it aims to answer are:

Read more

Does intraoperative kappa-angle compensation reduce postoperative higher-order aberrations after SMILE? Does kappa-angle compensation improve postoperative visual quality and refractive outcomes compared with no compensation?

Researchers will compare SMILE with intraoperative kappa-angle compensation to SMILE without compensation to determine whether compensation leads to better optical quality and visual performance.

Participants will:

Undergo SMILE surgery with or without intraoperative kappa-angle compensation Complete scheduled postoperative examinations at 1 week, 1 month, 3 months, and 6 months after surgery Receive measurements of visual acuity, refraction, higher-order aberrations, contrast sensitivity, and safety outcomes

Read the detailed description

Angle kappa refers to the offset between the visual axis and the pupil center and may influence the centration of the treatment zone during corneal refractive surgery. Inaccurate centration can lead to decentered ablation and may affect postoperative visual quality, especially higher-order aberrations. With the development of femtosecond laser technology, more precise intraoperative alignment has become possible.

Small incision lenticule extraction (SMILE) is a commonly used corneal refractive procedure with good safety and predictability. The VisuMax 800 system incorporates machine vision-assisted centration guidance, which allows intraoperative adjustment of the treatment center according to the relative position of the corneal vertex and the pupil center. This provides the possibility of performing intraoperative compensation based on the kappa-angle offset.

Previous studies have mainly evaluated centration adjustment in eyes with relatively large kappa-angle offsets and suggested that compensation may improve postoperative optical quality. However, for patients with small offsets, the necessity of intraoperative compensation remains unclear, and prospective randomized clinical trials are limited.

The purpose of this study is to compare the visual outcomes and optical quality after SMILE with or without intraoperative kappa-angle compensation in patients with small kappa-angle offsets.

This study is a single-center, randomized, parallel-group clinical trial. Participants who are suitable for SMILE surgery and have a kappa-angle offset less than 0.2 mm will be enrolled and randomly assigned to receive SMILE with compensation or SMILE without compensation using the VisuMax 800 platform.

All surgeries will be performed by experienced surgeons using standard SMILE procedures. Participants will undergo routine ophthalmic examinations before surgery and will be followed after surgery at scheduled visits.

The main evaluation will assess postoperative visual quality and refractive outcomes. Additional assessments will include visual acuity, refractive accuracy, higher-order aberrations, contrast sensitivity, and safety outcomes.

Being tested
Apply compensation to the Kappa angle., Apply no compensation to the Kappa angle
Keywords
myopia, SMILE, Refractive Surgery, Randomized Clinical Trial, Angle Kappa, VisuMax 800
Medical subject headings
Myopia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Apply compensation to the Kappa angle.Procedure or surgery

    SMILE PRO is an upgraded version/procedural designation of SMILE (Small Incision Lenticule Extraction) performed on the ZEISS VisuMax 800 femtosecond laser platform and remains, in essence, an all-femtosecond corneal refractive procedure. Its basic principle is to use a femtosecond laser to create a lenticule within the corneal stroma together with a small incision, and then remove the lenticule through that incision, thereby reshaping the corneal curvature to correct myopia and astigmatism. In the compensation group, during preoperative parameter input, a fixed intraoperative laser centration compensation of 0.1 mm was uniformly applied to all study eyes meeting the inclusion criteria to achieve a quantitative adjustment of the treatment center toward the visual axis.

  • Apply no compensation to the Kappa angleProcedure or surgery

    SMILE PRO is an upgraded version/procedural designation of SMILE (Small Incision Lenticule Extraction) performed on the ZEISS VisuMax 800 femtosecond laser platform and remains, in essence, an all-femtosecond corneal refractive procedure. Its basic principle is to use a femtosecond laser to create a lenticule within the corneal stroma together with a small incision, and then remove the lenticule through that incision, thereby reshaping the corneal curvature to correct myopia and astigmatism. In the non-compensation group, no kappa-angle-based laser centration compensation was applied intraoperatively, and the treatment center was set according to the system's default centration method.

Study groups in NCT07512115
Study groupRoleWhat they receive
Non-compensation groupActive comparatorSubjects underwent SMILE surgery on the VisuMax 800 platform. Preoperative offset coordinates (x, y) were measured; however, while preserving the directional sign, no kappa-angle-based laser centration compensation was applied intraoperatively, and the treatment center was set according to the system's default centration method. Except for the difference in compensation strategy, all other surgical procedures and postoperative management were identical to those in the compensation group.
Receives: Procedure: Apply no compensation to the Kappa angle
Compensation groupExperimentalSubjects underwent SMILE surgery on the VisuMax 800 platform. Preoperative offset coordinates (x, y) were measured, and, while preserving the directional sign, a fixed intraoperative laser centration compensation of 0.1 mm was uniformly applied to all eligible study eyes to achieve a quantitative adjustment of the treatment center toward the visual axis. Except for the difference in compensation strategy, all other surgical procedures and postoperative management were identical to those in the non-compensation group.
Receives: Procedure: Apply compensation to the Kappa angle.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Coma aberration

    Coma aberration measured by wavefront aberrometry to evaluate the effect of intraoperative kappa-angle compensation on postoperative optical quality.

    Measured: 3 months after surgery

Secondary outcomes (10)
  1. Higher-order aberrations

    Total higher-order aberrations, spherical aberration, and trefoil aberration measured using wavefront aberrometry under standardized conditions to evaluate postoperative optical quality.

    Measured: 1 month, 3 months, and 6 months after surgery

  2. Optical zone decentration

    Decentration of the optical zone measured using corneal topography by determining the displacement between the optical zone center and the corneal vertex.

    Measured: 3 months after surgery

  3. Visual acuity

    Binocular uncorrected distance visual acuity and corrected distance visual acuity measured using standardized visual acuity charts to evaluate visual performance and safety.

    Measured: 1 month, 3 months, and 6 months after surgery

  4. Manifest refraction

    Postoperative sphere, cylinder, and spherical equivalent measured by manifest refraction.

    Measured: 1 month, 3 months, and 6 months after surgery

  5. Refractive accuracy

    Proportion of eyes within predefined ranges of target refraction to evaluate refractive predictability.

    Measured: 1 month, 3 months, and 6 months after surgery

  6. Refractive stability

    Refractive stability will be assessed as the change in manifest spherical equivalent refraction between postoperative visits.

    Measured: 1 month to 6 months after surgery

  7. Contrast sensitivity

    Contrast sensitivity will be measured using a standardized contrast sensitivity testing system (CSV-1000, VectorVision, USA) at multiple spatial frequencies.

    Measured: 3 months after surgery

  8. Quality of Vision (QoV) score

    Visual symptoms will be assessed using the Quality of Vision (QoV) questionnaire, which evaluates the frequency, severity, and bothersome nature of visual disturbances. Scores are recorded on ordinal scales, with higher scores indicating worse visual quality.

    Measured: 3 months after surgery

  9. Patient satisfaction score

    Patient satisfaction will be assessed using a 5-point rating scale. Scores range from 1 to 5, with higher scores indicating greater satisfaction.

    Measured: 3 months after surgery

  10. Adverse events

    Incidence of intraoperative or postoperative complications, including loss of corrected distance visual acuity and other clinically significant events.

    Measured: Up to 6 months after surgery

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted6 Apr 2026
  2. Study start8 Apr 2026
  3. Primary completion30 May 2027 (estimated)
  4. Study completion30 May 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
224 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07512115
Sponsor's protocol ID
IIT2025199
Status last verified
Jul 2026
First submitted
21 Mar 2026
Last updated
7 Jul 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Doostparast A, Ghandhari M, Rastegar M, Khosronejad AH, Ghandhari M, Eslampoor A. Distribution and inter-device agreement of chord mu/alpha lengths and axes between Pentacam HR, Sirius, and IOLMaster 700. Photodiagnosis Photodyn Ther. 2025 Dec;56:105275. doi: 10.1016/j.pdpdt.2025.105275. Epub 2025 Nov 6.

    PubMed 41205666
  • Shao T, Wang Y, Ng ALK, Chan TCY, Hao W, Zhang J, Cheng GPM, Jhanji V. The Effect of Intraoperative Angle Kappa Adjustment on Higher-Order Aberrations Before and After Small Incision Lenticule Extraction. Cornea. 2020 May;39(5):609-614. doi: 10.1097/ICO.0000000000002274.

    PubMed 32040010
  • Lai X, Liu X, Zeng T, Huang Y, Yang X. Comparison of visual outcomes and optical aberrations after SMILE with intraoperative Kappa angle adjustments between small and large Kappa angles. Sci Rep. 2024 Jun 24;14(1):14551. doi: 10.1038/s41598-024-65366-w.

    PubMed 38914606
  • Deng M, Zhou D, Li M, Shi Y, Sun L, Zou J, Ma X. Evaluation of corneal asymmetry and higher-order aberrations after small incision lenticule extraction for moderate and high myopia. Int Ophthalmol. 2025 Jun 1;45(1):218. doi: 10.1007/s10792-025-03576-5.

    PubMed 40451982
  • Vingopoulos F, Zisimopoulos A, Kanellopoulos AJ. Comparison of effective corneal refractive centration to the visual axis: LASIK vs SMILE, a contralateral eye digitized comparison of the postoperative result. J Cataract Refract Surg. 2021 Dec 1;47(12):1511-1518. doi: 10.1097/j.jcrs.0000000000000687.

    PubMed 34074993
  • McAlinden C, Pesudovs K, Moore JE. The development of an instrument to measure quality of vision: the Quality of Vision (QoV) questionnaire. Invest Ophthalmol Vis Sci. 2010 Nov;51(11):5537-45. doi: 10.1167/iovs.10-5341. Epub 2010 May 26.

    PubMed 20505205
  • Chang JS, Law AK, Ng JC, Chan VK. Comparison of refractive and visual outcomes with centration points 80% and 100% from pupil center toward the coaxially sighted corneal light reflex. J Cataract Refract Surg. 2016 Mar;42(3):412-9. doi: 10.1016/j.jcrs.2015.09.030.

    PubMed 27063522

Questions about this trial

What is this clinical trial studying?

A study testing Apply compensation to the Kappa angle. and Apply no compensation to the Kappa angle in people with Myopia and Refractive Ametropia, run by Zhongshan Ophthalmic Center, Sun Yat-sen University at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Coma aberration (time frame: 3 months after surgery). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07512115, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jul 2026.

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